On May 13, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, Xenetic Biosciences, MAY 13, 2019, View Source [SID1234536226]).

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"We expect 2019 to be a transformative year for Xenetic. With the anticipated closing of our acquisition of XCART, our differentiated CAR T platform technology, on track for this quarter, I believe Xenetic will be well positioned to drive momentum in the innovation and development of new oncology therapeutics where there remains significant unmet need," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "We plan to focus our R&D efforts initially on leveraging the XCART platform to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas. All of this marks a very important moment in the evolution of Xenetic, and I firmly believe the Company can become a significant player in the oncology space with this potentially transformative technology platform, providing therapeutic solutions for physicians and individuals fighting cancer and their families as well as driving value for our shareholders."

XCART Technology

On March 1, 2019, the Company entered into agreements to acquire a novel CAR T ("Chimeric Antigen Receptor T Cell") platform technology, called "XCART." XCART is a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. The XCART technology, developed by The Scripps Research Institute in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells. The acquisition is subject to conditions typical for a transaction of this kind, including appropriate stockholder approvals, and is expected to close by the end of the second quarter.

The XCART technology platform was designed by its originators to utilize an established screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor ("BCR") on the surface of an individual patient’s malignant tumor cells. The peptide is then inserted into the antigen-binding domain of a CAR, and a subsequent transduction/transfection process is used to engineer the patient’s T cells into a CAR T format which redirects the patient’s T cells to attack the tumor. Essentially, the XCART screening platform is the inverse of a typical CAR T screening protocol wherein libraries of highly specific antibody domains are screened against a given target. In the case of XCART screening, the target is itself an antibody domain, and hence highly specific by its nature. The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.

An expected result for XCART is reduced off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Once the acquisition is consummated, the Company intends to pursue development efforts of the XCART technology as well as other development efforts in the area of CAR T therapy.

Summary of Financial Results for First Quarter 2019

Net loss for the three months ended March 31, 2019, was approximately $1.3 million compared to a net loss of approximately $1.8 million for the same period in 2018. Working capital (deficit) was approximately $1.2 million and $(0.4) million at March 31, 2019 and December 31, 2018, respectively. During the quarter ended March 31, 2019, the Company’s working capital increased by $1.6 million due to the issuance of common stock and warrants in our March 2019 offering resulting in $2.7 million of net proceeds to Xenetic. The Company ended the quarter with approximately $2.0 million of cash.

On May 13, 2019 Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, reported the United States Food and Drug Administration (FDA) has granted orphan drug designation to P-BCMA-101 for the treatment of relapsed and/or refractory multiple myeloma (Press release, Poseida Therapeutics, MAY 13, 2019, View Source [SID1234536247]). P-BCMA-101 is an autologous CAR-T therapy developed using Poseida’s piggyBac platform technology. P-BCMA-101 is comprised of a high percentage of long-lived, self-renewing stem cell memory T cells targeting cancer cells expressing B-cell maturation antigen (BCMA).

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"FDA orphan designation is an important regulatory milestone in the continued development and commercialization of P-BCMA-101," said Eric Ostertag, M.D., Ph.D., chief executive officer of Poseida. "P-BCMA-101 has demonstrated outstanding potency, with strikingly low rates of toxicity in our phase 1 clinical trial. In fact, the FDA has approved fully outpatient dosing in our Phase 2 trial starting in the second quarter of 2019."

Poseida’s non-viral piggyBac DNA Modification System results in CAR-T product candidates with a high percentage of stem cell memory T cells (Tscm), the only T cell that is self-renewing and long-lived, leading to CAR-T products with improved efficacy, lower toxicity and potentially greater durability than earlier generation CAR-T therapies.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits and seven years of market exclusivity in the United States following marketing approval by the FDA.

Poseida has received grant funding from the California Institute for Regenerative Medicine to support the clinical development of P-BCMA-101.

On May 13, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its research partner, the University of Northern Colorado, has bioengineered a human cell line designed to activate a cannabinoid prodrug in its quest to develop a Cell-in-a-Box/cannabinoid therapy for serious forms of cancer, particularly brain cancer (Press release, PharmaCyte Biotech, MAY 13, 2019, View Source [SID1234536211]).

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Mark L. Rabe, MD, PharmaCyte’s Director of Cannabis Program Development, commenting on the bioengineered cell line said, "We now have a cell line into which the gene for a putative cannabinoid prodrug-activating enzyme has been ‘transfected’ or inserted into the cell’s DNA. The gene was synthesized de novo using knowledge of the underlying genetic code of the cell. The cell line is the same human cell line that will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

"The next step is to test the efficiency of the transfected cells in converting cannabinoid prodrugs into their active cancer-fighting forms. If the cells are suitably active, they would then be propagated to the point that they can then be encapsulated using the Cell-in-a-Box technology. Also, we will continue our analysis of other genes of interest that could be used in a similar way."

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "As we advance our Cell-in-a-Box + ifosfamide therapy for LAPC with the U.S. FDA through preparation and submission of an Investigational New Drug application, we are pleased to report on the work done at the University of Northern Colorado. Such news as this serves to contribute to PharmaCyte’s efforts as we work diligently to develop treatments for deadly diseases and build shareholder value."

The current objective of PharmaCyte’s Cannabis Program is to develop targeted cannabinoid-based chemotherapy by bioengineering a cell line that produces a cannabinoid prodrug-activating enzyme, encapsulating this cell line utilizing the Cell-in-a-Box platform and implanting the encapsulated cells near the site of a tumor. A cannabinoid prodrug would then be administered and activated at the site of the tumor where its anti-cancer effects are needed. PharmaCyte’s research conducted by the University of Northern Colorado has confirmed that a cannabis-based approach may prove to be efficacious in the treatment of several different types of cancers.

On May 13, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, Neon Therapeutics, MAY 13, 2019, View Source [SID1234536227]).

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"The field of cancer immunotherapy has advanced considerably in recent years, but there remains a significant need for new approaches that could extend the benefits of immunotherapy and lead to improved patient outcomes. Neoantigen-based therapies hold the promise to transform the treatment of cancer and we are proud of our leadership in pursuing these untapped targets," said Hugh O’Dowd, Neon’s Chief Executive Officer. "We continue to make important progress across the Company, including our efforts to establish RECON as the best-in-class neoantigen bioinformatic prediction engine with our machine learning and proteomics expertise. We intend to further strengthen our position as a class-leader in neoantigen selection by continuing to leverage proprietary immunogenicity data from our ongoing clinical studies. We remain excited about numerous upcoming clinical milestones, including the top-line results from our NT-001 study of NEO-PV-01, which we expect to be the first clinical dataset ever reported with 12-month follow-up for a personal neoantigen vaccine in metastatic melanoma, non-small cell lung and bladder cancers."

Pipeline Updates
Neon is developing neoantigen-targeting therapies across multiple treatment modalities, including vaccines, adoptive T cell therapies and TCR-based T cell therapies to bring benefit to a broad set of patients across tumor types and stages of disease. This approach requires effectively identifying and selecting the optimal neoantigen targets for the unique mutational fingerprint of each individual patient’s tumor. Neon is pioneering a proprietary neoantigen platform to identify and harness the most therapeutically relevant neoantigens, including through its RECON bioinformatic neoantigen prediction engine, deep capabilities in peptide chemistry and manufacturing, and NEO-STIM T cell biology and immune-monitoring expertise.
Neon is using two distinct neoantigen therapeutic approaches across this platform: personal therapies that target individualized mutations (NEON / ONE), and off-the-shelf precision therapies (NEON / SELECT) that target shared mutations present in sub-populations of cancer patients.
"Neon is pursuing novel therapeutic approaches at the frontiers of immuno-oncology. We designed our R&D strategy to enable us to determine how our neoantigen-targeted platform and product candidates could improve patient outcomes beyond the limitations of current standard of care treatment. Our near-term R&D strategy is focused on leveraging Phase 1b clinical trials to determine the optimal patient selection, rational combinations and trial designs to inform subsequent Phase 2 and later stage clinical trials," said Richard Gaynor, M.D., Neon’s President of Research and Development.
NEON / ONE is Neon’s personal medicine approach to neoantigen-targeted therapies that are tailored for the individual profile of each patient’s tumor. Neon’s initial clinical strategy has focused on solid tumor indications where checkpoint inhibitors have been approved, either in combination or in refractory settings.

NEO-PV-01: Personal Neoantigen Vaccine

NEO-PV-01: Neon is evaluating its lead product candidate, a personal neoantigen vaccine, in a variety of treatment settings in Phase 1b development to determine the optimal late-stage clinical trials.

NT-001 Trial: Neon’s ongoing Phase 1b open-label clinical trial is evaluating a combination of NEO-PV-01 with OPDIVO (nivolumab) in patients with metastatic melanoma, non-small cell lung cancer (NSCLC) or bladder cancer.

Neon recently presented updated data from NT-001 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, describing the immune and pathologic markers associated with study subjects remaining progression-free at nine months. The analysis both confirmed the mechanism of action of NEO-PV-01 and highlighted new data on the association between histology and epitope spread in patients who had not progressed at nine months in the melanoma cohort. In addition, multiple molecular markers were determined to correlate with lack of clinical progression, which may prove useful for patient selection in late-stage clinical trials.

Neon expects to report top-line clinical results, including 12-month follow-up, from NT-001 in July 2019. The results are expected to include data from an intention-to-treat (ITT) analysis from 82 enrolled patients, including median progression-free survival (PFS) and objective response rates (ORR), safety and baseline patient characteristics in each of the three tumor cohorts.

NT-002 Trial: Neon recently completed enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 in combination with the current standard of care, KEYTRUDA (pembrolizumab) and chemotherapy, in first-line patients with untreated advanced or metastatic NSCLC. This trial is evaluating the safety, tolerability and efficacy of NEO-PV-01 in the metastatic setting. Neon expects to report immune monitoring and clinical outcome data from this trial by the end of Q3 2020.

NT-003 Trial: This Phase 1b clinical trial of NEO-PV-01 in metastatic melanoma combinations is currently enrolling. NT-003 will evaluate NEO-PV-01 and OPDIVO in combination with other agents, including Apexigen’s CD40 agonist (APX005M) or a CTLA-4 antagonist, to further enhance any NEO-PV-01-induced neoantigen immune response and improve clinical outcomes. This trial will also evaluate alternative NEO-PV-01 dosing schedules. Neon plans to announce immune monitoring data from this study in 2H 2020.

NT-004 Trial: Neon is planning to explore NEO-PV-01 in a monotherapy approach in an earlier disease setting in this Phase 1b trial.

NEO-PTC-01: Personal Neoantigen T cell Therapy

NEO-PTC-01: Neon’s personal adoptive T cell therapy consists of multiple T cell populations targeting neoantigens that are predicted to be the most therapeutically relevant from each patient’s tumor. NEO-PTC-01 uses T cells from the periphery of each patient that are then primed, activated and expanded to generate a therapy that specifically targets that patient’s personal neoantigens, with the potential to drive a robust and persistent anti-tumor response.

CTA Filing: Building on success to date in generating both memory and de novo immune responses, Neon is completing process development, which supports its plan to file a Clinical Trial Application (CTA) in Europe in the second half of 2019 to evaluate NEO-PTC-01 in refractory solid tumor settings. This work is being performed in collaboration with the Netherlands Cancer Institute (NKI), a leading academic research and treatment center with expertise in T cell biology and treatments.
NEON / SELECT is Neon’s off-the-shelf precision approach to neoantigen-targeted therapies that seek to target prevalent neoantigens that are shared across subsets of patients or tumor types.

NEO-SV-01: Breast Neoantigen Vaccine

NEO-SV-01: Neon is planning to develop its off-the-shelf neoantigen vaccine for the treatment of a genetically-defined subset of hormone receptor-positive (HR+) breast cancer, potentially across disease stages in combination with hormonal, chemotherapy or targeted therapies.

IND Filing: Following the completion of target validation and preclinical product development work, Neon expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a Phase 1b clinical trial of NEO-SV-01 in Q2 2019.

TCR-based T cell Therapies

TCRs: Neon continues to advance its precision T cell approach and has assembled libraries of high-quality T-cell receptors (TCRs) against various shared neoantigens. Neon is leveraging its proprietary NEO-STIM

induction protocol to rapidly generate T cells specific to these targets where multiple TCRs can be sequenced and characterized.
Expected Milestones
Clinical Trial Results:

NEO-PV-01: Top-line clinical results, including 12-month follow-up, from NT-001 Phase 1b trial in metastatic melanoma, NSCLC and bladder cancers (July 2019)

NEO-PV-01: Clinical results and correlative immune data from NT-001 Phase 1b trial planned for presentation at a medical congress (2H 2019)

NEO-PV-01: Clinical results and correlative immune data, including 12-month follow-up, from NT-002 Phase 1b trial in first-line metastatic NSCLC (Q3 2020)

NEO-PV-01: Immune data from NT-003 Phase 1b trial in metastatic melanoma combinations (2H 2020)
Clinical Trial Applications/Initiations:

NEO-SV-01: U.S. IND filing to evaluate NEO-SV-01 in a genetically defined subset of HR+ breast cancer (Q2 2019)

NEO-PTC-01: European CTA filing to evaluate NEO-PTC-01 in a refractory solid tumor setting (2H 2019)
First Quarter 2019 Financial Results and Financial Guidance:

R&D Expenses: Research and development expenses were $16.2 million for the first quarter of 2019, compared to $13.2 million for the same period last year. The increase was primarily due to costs related to research and development of NEO-PV-01, NEO-PTC-01 and NEO-SV-01, as well as investments in R&D headcount to support the advancement of Neon’s pipeline.

G&A Expenses: General and administrative expenses were $5.4 million for the first quarter of 2019, compared to $3.6 million for the same period last year. The increase was primarily due to personnel-related expenses, professional fees to support expanding operations and costs associated with being a public company.

Net Loss: Net loss attributable to common stockholders was $21.0 million for the first quarter of 2019, compared to $19.7 million for the same period last year.

Cash Position: As of March 31, 2019, cash, cash equivalents and marketable securities were $81.3 million, as compared to cash, cash equivalents and marketable securities of $103.3 million as of December 31, 2018.

Financial Guidance: Based on its current operating plan, Neon expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into at least Q2 2020.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On May 13, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, reported financial results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, TCR2 Therapeutics, MAY 13, 2019, View Source [SID1234536248]).

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"In our first quarter as a public company, TCR2 has continued to execute our vision and objectives," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "During the quarter, we initiated our Phase 1/2 trial for TC-210, progressed TC-110 toward IND submission in the second half of 2019, and highlighted the differentiation of our novel TRuC-T cells in scientific presentations at Keystone Symposia on Cancer Immunotherapy, AACR (Free AACR Whitepaper) and CAR-T Congress USA. These preclinical studies underscore TRuC-T cells’ greater anti-tumor activity, longer persistence, and less cytokine release compared to CAR-T cells."

Recent Developments

In January 2019, the FDA cleared the IND for TC-210. TCR2 initiated its Phase 1/2 trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. TCR2 anticipates providing an update on the trial before the end of the 2019.

In February 2019, TCR2 completed an initial public offering pursuant to which it issued and sold 5,750,000 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in net proceeds of $80.2 million after deducting underwriting discounts and commissions.

In February 2019, the FDA granted orphan drug designation to TC-210 for the treatment of mesothelioma.

In February 2019, TCR2 held a pre-IND meeting with the FDA and remains on track to submit an IND for TC-110 in patients with CD19+ non-Hodgkin lymphomas and leukemias in the second half of 2019.

In February 2019, the United States Patent and Trademark Office issued U.S. Patent No.: 10,208,285, with claims covering TCR2’s TRuC-T cells that express anti-mesothelin TCR fusion proteins, including TC-210.

In March 2019, TCR2 presented two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 featuring preclinical data for TC-110 and TC-210.

In March 2019, TCR2 established occupancy of its manufacturing suite at Cell and Gene Therapy (CGT) Catapult in the UK.

In May 2019, TCR2 published preclinical data in the peer-reviewed journal Nature Communications demonstrating the advantages of TRuC-T cells compared to CAR-T cells. In the paper entitled, "Synthetic TRuC receptors engaging the complete T cell receptor for potent anti-tumor response," the findings, consistent with the Company’s previously reported preclinical data, support the Company’s belief that its product candidates could improve the observed efficacy and safety of other adoptive T-cell therapies in development.

TC-210 Clinical Trial Design

The Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of TC-210, TCR2’s T-cell receptor fusion construct against mesothelin. The trial is enrolling patients with mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma, and malignant pleural/peritoneal mesothelioma.

The Phase 1 portion of the clinical trial utilizes a 3+3 design with four escalating dose levels for TC-210. At each dose level, TC-210 will be first tested without lymphodepletion and then following lymphodepleting chemotherapy. The primary objective for the study is patient safety with a key secondary objective to determine the recommended Phase 2 dose (RP2D). In addition to standard measures of safety and efficacy, translational work includes assessment of patients’ tissues for expansion, trafficking, and persistence of TC-210 T cells.

In the Phase 2 portion of the clinical trial, approximately 50 patients are planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Each cohort includes ten patients, except the NSCLC cohort which includes 20 patients with eight patients to receive TC-210 as single agent and 12 to receive TC-210 in combination with a programmed cell death 1 (PD-1) blocking antibody.

Summary of Recent Presentations and Publications

Keystone Symposia on Molecular and Cellular Biology: Cancer Immunotherapy
Robert Hofmeister, Ph.D., Chief Scientific Officer, delivered an oral presentation, "Preclinical Evaluation of TC-210, a Mesothelin-Specific T Cell Receptor (TCR) Fusion Construct (TRuCTM) T Cells for the Treatment of Solid Tumors."

AACR Annual Meeting 2019
The Company presented two posters on the preclinical evaluation of TC-210 and TC-110 demonstrating superior in vivo anti-tumor activity compared to CAR-T cells with the same binders, including evidence that the anti-tumor activity of TRuC-T cells, both in vitro and in vivo, does not require added co-stimulatory signals.

CAR-T Congress USA 2019
Robert Hofmeister, Ph.D., Chief Scientific Officer, delivered an oral presentation on the features of the TRuC-T cell platform, "Utilizing the Entire T Cell Receptor Independent of HLA for a Broad and Controlled Anti-Tumor Response."

Nature Communications
The Company published preclinical data demonstrating the advantages of TRuC-T cells compared to CAR-T cells. In the paper entitled, "Synthetic TRuC receptors engaging the complete T cell receptor for potent anti-tumor response," the findings, consistent with the TCR2’s previously reported preclinical data, support the Company’s belief that its product candidates could improve the observed efficacy and safety of other adoptive T-cell therapies in development.

Financial Highlights
Cash Position: TCR2 ended 1Q 2019 with $191.7 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash from the Company’s initial public offering in 1Q 2019 was $80.2 million. Net cash used in operations was $10.8 million for 1Q 2019 compared to $3.0 million in 1Q 2018. TCR2 projects net cash use of $45-55 million in 2019.

R&D Expenses: Research and development expenses were $7.9 million for the first quarter of 2019 compared to $2.9 million for the first quarter of 2018. The increase in R&D expenses is primarily related to increase in headcount and activities related to the start of the Phase 1/2 clinical trial of the Company’s lead solid tumor product candidate, TC-210.

G&A Expenses: General and administrative expenses were $2.9 million for the first quarter of 2019 compared to $1.2 million for the first quarter of 2018. The increase in general and administrative expenses was primarily due to an increase in personnel costs and cost associated with operations as a public company.

Net loss: Net loss was $9.9 million for the first quarter of 2019 compared to $4.0 million for the first quarter of 2018, driven predominantly by increased R&D expense in the quarter.

Upcoming Events
TCR2 Therapeutics management are scheduled to present at the following upcoming conferences.

Jefferies Global Healthcare Conference: Alfonso Quintás Cardama, M.D., Chief Medical Officer and Ian Somaiya, Chief Financial Officer, will present on Wednesday, June 5th, 2019 at 10:30am ET in New York, NY.

BMO 2019 Prescriptions for Success Healthcare Conference: Robert Hofmeister, Ph.D., Chief Scientific Officer, will present on Thursday, June 25, 2019 at 3:40pm ET in New York, NY.

Conference Call Details
TCR2 will host a conference call and live audio webcast to discuss results and provide a corporate update at 5:00 PM ET today. The live call may be accessed by dialing (866) 220-8062 for domestic calls or (470) 495-9169 for international calls and referencing conference ID 2063908. A live audio webcast for the conference call will be available on the Investors page of the Company’s website at investors.tcr2.com. Following the conclusion of the call, the webcast will be available for replay for 30 days.